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|Mesalamine Controlled-Release Capsules

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Mesalamine Controlled-Release Capsules

Generic Name: Mesalamine Controlled-Release Capsules (me-SAL-a-meen)
Brand Name: Pentasa

Mesalamine Controlled-Release Capsules is used for:

Treating and causing remission of various forms of mild to moderate ulcerative colitis (inflammation of the colon). Mesalamine Controlled-Release Capsules may also be used to treat other conditions as determined by your doctor.

Mesalamine Controlled-Release Capsules is a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause the inflammation of the colon.

Do NOT use Mesalamine Controlled-Release Capsules if:

you are allergic to any ingredient in Mesalamine Controlled-Release Capsules, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen), or salicylates (eg, aspirin)
you are younger than 18 years of age and you have the flu or chicken pox
you are taking probenecid or sulfinpyrazone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mesalamine Controlled-Release Capsules:

Some medical conditions may interact with Mesalamine Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have had a stroke, bleeding in the brain, or an aneurysm
if you have liver or kidney problems, Kawasaki syndrome, the flu, chicken pox, or a rheumatic (inflammatory) disease (eg, osteoarthritis)

Some MEDICINES MAY INTERACT with Mesalamine Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Carbonic anhydrase inhibitors (eg, acetazolamide) because the effectiveness of Mesalamine Controlled-Release Capsules may be decreased
Gingko biloba extract because side effects, such as increased bleeding, may occur
Insulin, meglitinide antidiabetics (eg, repaglinide), sulfonylureas (eg, glipizide), or valproic acid because the actions and side effects of these medicines may be increased
Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), probenecid, or sulfinpyrazone because the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mesalamine Controlled-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mesalamine Controlled-Release Capsules:

Use this medicine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Mesalamine Controlled-Release Capsules may be taken with or without food. If stomach upset occurs, take with food or milk.
Swallow whole. Do not break, crush, or chew tablets.
If a dose is missed, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mesalamine Controlled-Release Capsules.

Important safety information:

Mesalamine Controlled-Release Capsules may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Mesalamine Controlled-Release Capsules. Using Mesalamine Controlled-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
Mesalamine Controlled-Release Capsules may cause increased sensitivity to sunlight. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Mesalamine Controlled-Release Capsules. Use sunscreen or protective clothing if you must be outside for a prolonged period.
Use Mesalamine Controlled-Release Capsules with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Mesalamine Controlled-Release Capsules during pregnancy. Mesalamine Controlled-Release Capsules is excreted in breast milk. If you are or will be breast-feeding while using Mesalamine Controlled-Release Capsules, contact your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Mesalamine Controlled-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; back or joint pain; diarrhea; dizziness; gas; hair loss; headache; heartburn; increased sensitivity to sunlight; loss of appetite; mild abdominal discomfort or pain; nausea; runny or stuffy nose; sneezing.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bloody or coffee ground-like vomit; fever, chills, or sore throat; severe cramping; severe headache; severe or sudden stomach pain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; dehydration; diarrhea; dizziness; drowsiness; fever; headache; quick and short breathing; ringing in the ears; sweating; vomiting.

Proper storage of Mesalamine Controlled-Release Capsules:

Store Mesalamine Controlled-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mesalamine Controlled-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Mesalamine Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Mesalamine Controlled-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Mesalamine Controlled-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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